亚胺培南西司他丁钠仿制药与原研药的临床疗效和安全性比较

Comparison of clinical efficacy and safety between generic and branded imipenem and cilastatin sodium

目的比较亚胺培南西司他丁钠仿制药(商品名:俊特)与其原研药(商品名:泰能)的临床疗效和安全性,为临床用药的合理选择提供参考。方法回顾性纳入2017年6月至2018年6月使用亚胺培南西司他丁钠(俊特或泰能)超过72 h的全部病例。主要观察指标包括临床有效率、住院死亡率、不良反应发生率和革兰阴性菌清除率。采用1:1倾向性评分匹配,以控制2组间混杂因素。结果共1433例患者(总体样本:仿制组672例;原研组761例)纳入分析。匹配后的总体样本中,仿制组(n=496)和原研组(n=496)的临床有效率为84.1%和81.7%(P=0.312),住院死亡率为4.6%和5.4%(P=0.562),神经毒性发生率为0.6%和0.4%(P=1.000),过敏反应发生率为0.6%和1.2%(P=0.506)。仿制药和原研药对常见革兰阴性敏感菌的清除率分别为85.9%和80.8%(P=0.390)。进一步亚组分析,仿制药和原研药单药治疗以及两者治疗肺部感染、腹腔感染和多部位感染的临床有效率和住院死亡率的差异也均无统计学意义(P>0.05)。在匹配后的总体样本中采用最小成本分析法进行经济学评价,结果显示仿制组的亚胺培南西司他丁钠平均成本和抗菌药物平均成本均低于原研组(2889元vs 3723元和19399元vs 24900元)。结论亚胺培南西司他丁钠仿制药(俊特)与其原研药(泰能)治疗肺部感染、腹腔感染和多部位感染的临床疗效以及基于神经毒性和过敏反应的安全性相似,仿制药相对于原研药具有较大的经济学优势。

AIM To compare the clinical efficacy and safety between generic(trade name:Junte)and branded(trade name:Tienam)imipenem and cilastatin sodium,providing reference for the rational choice of clinical medication.METHODS All patients who used imipenem and cilastatin sodium(Junte or Tienam®for more than 72 h from June 2017 to June 2018 were retrospectively included.The main outcome measures included clinical response rate,hospital mortality rate,the incidence of adverse reactions and the clearance rate of gram-negative bacteria.The 1:1 propensity score matching was performed to control the confounding factors between groups.RESULTS A total of 1433 patients(overall sample:672 in generic group;761 in branded group)were included in the analysis.In the matched overall sample,the clinical response rate of generic group(n=496)and branded group(n=496)was 84.1%and 81.7%(P=0.312);the hospital mortality rate was 4.6%and 5.4%(P=0.562);the incidence of neurotoxicity was 0.6%and 0.4%(P=1.000);the incidence of allergic reaction was 0.6%and 1.2%(P=0.506).The clearance rate of generic drug and branded drug on common gramnegative sensitive bacteria was 85.9%and 80.8%,respectively(P=0.390).Further subgroup analysis found that there were no statistically significant differences in the clinical response rate and the hospital mortality rate between generic and branded monotherapy and both drugs in the treatment of pulmonary infection,abdominal infection and multiple site infection(P>0.05).Economic evaluation was conducted using cost minimization analysis in the matched overall sample.The results showed that the average cost(RMB)of imipenem and cilastatin sodium and the average cost(RMB)of antibacterial drugs in the generic group were both lower than those in the branded group(2889 vs 3723 and 19399 vs 24900).CONCLUSION The clinical efficacy in the treatment of pulmonary infection,abdominal infection,and multiple site infection and the safety based on neurotoxicity and allergic reaction between generic(Junte)and branded(Tienam)imipenem and cilastatin sodium are similar,and generic drug has a greater economic advantage over branded drug.